Risks for ADHD Drugs Outlined in Patient Guides
The Food and Drug Administration has directed manufacturers of medications approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides that alert patients about possible risks of cardiovascular and psychiatric adverse events.
Patient Medication Guides are handouts given to patients, families, and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. People being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.
An FDA review of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in people with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.
Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.
FDA Recommendations for Patients
The FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physicians or other health care professionals to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including an assessment for a family history of such problems).
The medications that are the focus of the Patient Medication Guides include:
- Adderall (mixed salts of a single entity amphetamine product) Tablets
- Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
- Concerta (methylphenidate hydrochloride) Extended-Release Tablets
- Daytrana (methylphenidate) Transdermal System
- Desoxyn (methamphetamine HCl) Tablets
- Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
- Focalin (dexmethylphenidate hydrochloride) Tablets
- Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
- Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
- Methylin (methylphenidate hydrochloride) Oral Solution
- Methylin (methylphenidate hydrochloride) Chewable Tablets
- Ritalin (methylphenidate hydrochloride) Tablets
- Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
- Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
- Strattera (atomoxetine HCl) Capsules
The draft Patient Medication Guides for each product can be found at www.fda.gov/FDAgov/ForConsumers/ConsumerUpdates/ucm107918.htm.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: April 23, 2007